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31 mars

Watch Out for Mandatory Japanese Encephalitis Vaccine

This article calls Japanese encephalitis a "mosquito-transmitted" disease. Now, I suppose that means that it's a bloodborne pathogen. HIV is also a bloodborne pathogen, and I think I recall hearing that someone was likely infected with HIV via mosquito ... maybe reported in the Lancet ... around 1995. It doesn't mean that it's likely that an American will get Japanese encephalitis (or HIV) from a moquito. In fact, it's probably less likely than the possibility that someone receiving this vaccine will suffer adverse effects. Give the government a year, though, and I'll bet it'll be required for entrance into public school.
 
 

RPT-US FDA approves Intercell's encephalitis vaccine

Mon Mar 30, 2009 6:51pm EDT
 

WASHINGTON, March 30 (Reuters) - The U.S. Food and Drug Administration said on Monday it had approved a vaccine against Japanese encephalitis made by Austria-based Intercell AG (ICEL.VI).

The vaccine, called Ixiaro, would be the only vaccine for the mosquito-transmitted disease available in the United States. (Reporting by Maggie Fox) *(Maggie.Fox@Reuters.com; 1 202 898 8492)

Expect More States to Make HPV Vaccine Mandatory

...because now Cervarix, the GSK version of the vaccine, is heading for the US market. It's the only one available in the UK, thanks to the GSK-UK government bedfellows, and it's just as unnecessary and misleading as Gardasil. (Want to make it easier for girls to get pregnant and get other STDs? Encourage them to have unprotected sex!)
 
Note that the data submitted to the FDA are from an efficacy study, not a safety study. I wonder if Cervarix will kill and paralyze as many American girls as Gardasil has...
 
 
  • MARCH 30, 2009, 11:34 A.M. ET

    Glaxo Submits Cervarix Data to FDA; Expects Response in 6 Months

    By ELENA BERTON

    LONDON -- GlaxoSmithKline PLC said Monday that it has submitted final data for its application to market its cervical-cancer vaccine in the U.S., adding it expects a response in six months.

    Cervarix, which is expected to become a blockbuster product and a key growth driver for Glaxo, has been on hold with the Food and Drug Administration, despite having been approved in more than 90 countries around the world, including the 27 member states of the European Union.

    The Brentford, England-based company said the data filed with the FDA are from a late-stage efficacy study of more than 18,600 women between 15 and 25 years old.

    "The data submitted to the FDA reaffirm our confidence in the vaccine's safety and efficacy profile," said Barbara Howe, vice president and director of Glaxo's North American Vaccine Development unit.

    Cervarix vaccinates against human papillomavirus, a common cause of cervical cancer. Merck & Co.'s rival vaccine Gardasil has already been approved for use in the U.S. —The Associated Press contributed to this article.

    Write to Elena Berton at elena.berton@dowjones.com

  • 30 mars

    How Far Will US Government Bend Over for Bayer?

     
    Trying to Limit Disclosure on Explosion
     
    By SEAN D. HAMILL
    Published: March 28, 2009

    INSTITUTE, W.Va. — Last August, an explosion tore through the Bayer CropScience chemical plant here, killing two employees and raising the fears of residents in what has long been known as Chemical Valley.

    Now, a federal agency wants to hold a public hearing to lay out its preliminary findings about what caused the accident. But Bayer, citing a terrorism-related federal law, is trying to limit what the agency can disclose.

    Bayer contends that because it has a dock for barge shipments on the adjacent Kanawha River, its entire 400-acre site qualifies under the 2002 federal Maritime Transportation Security Act. It has asked the Coast Guard, which has jurisdiction under the act, to review the public release of “sensitive security information.”

    The agency that wants to hold the hearing, the Chemical Safety and Hazard Investigation Board, says it is the first time in its 11 years of operation that a company has tried to limit what could be discussed publicly, and the first time the maritime act has been invoked this way.

    “I don’t like the idea that if we went to a meeting in West Virginia and someone asked a question, we’d have to say, ‘Sorry, we can’t talk about it,’ ” said John S. Bresland, the board chairman. “We don’t think any other agency should have the right to tell us what we can put in our reports.”

    In particular, Bayer appears to want to limit discussion about the potential hazards posed by a chemical produced and used by the plant — methyl isocyanate, the same chemical responsible for the deaths of thousands of people in Bhopal, India, after a Union Carbide plant leaked there in 1984. Until 1986, Union Carbide owned the plant here, which was considered the sister plant.

    The chemical safety board believes that if Bayer is successful, it will set a precedent for other companies to limit the release of information.

    The board was modeled on the National Transportation Safety Board. And like the transportation board, it has no regulatory power, so it cannot fine a company or order changes in operations. Its power comes from revealing its findings and making recommendations.

    “We have a bully pulpit,” Mr. Bresland said, “and we use it by going out in public and talking about what we’ve found.”

    After Bayer invoked the maritime act in February, the chemical safety board canceled a March 19 public meeting in West Virginia while it sought to resolve the dispute. It has tentatively rescheduled the hearing for April 23 while awaiting the Coast Guard’s decision, which it could appeal to the Transportation Security Administration.

    Bayer’s action also caught the attention of Representative Bart Stupak, Democrat of Michigan and chairman of the House Subcommittee on Oversight and Investigations. Mr. Stupak scheduled an April 21 hearing to review the company’s action, saying, “We are concerned about the way that Bayer may be misusing terrorism laws to suppress information related to the incident.”

    Bayer believes it has a strong case for suppressing public discussion of its operations in West Virginia, said a company spokesman, Greg Coffey.

    “In security matters, the site comes under the jurisdiction of the Coast Guard,” Mr. Coffey said. “We have and will continue to comply with the spirit of the regulations” of the maritime act.

    And Bayer appears to have the support of the Coast Guard. A spokesman, Lt. Cmdr. Chris O’Neil, said that the service considered the entire plant, not just the dock, a “regulated facility,” and that “it might only be prudent to protect that information” Bayer does not want discussed.

    But Mr. Bresland said the chemical board contended that the maritime act applied only to transportation of the chemicals, not the onsite storage and processes. Methyl isocyanate, a chemical used in the production of carbamate pesticides, was not directly involved in the August explosion, which the company has said was caused by human error in a unit that contained the less toxic chemical methomyl.

    But an above-ground storage tank that can hold up to 40,000 pounds of methyl isocyanate was just 50 feet to 75 feet from the blast area, and a much larger underground tank in a different part of the plant site can store an additional 200,000 pounds. In the Bhopal disaster, 50,000 to 90,000 pounds of the chemical leaked.

    It is the onsite storage of the methyl isocyanate (or MIC) that has long concerned West Virginia environmentalists. After the Bhopal disaster, professors at West Virginia State University, which is next to the plant, and residents started People Concerned About MIC to monitor the plant.

    “One of the ironies is that in the 1980s, one of the demands we had was that Carbide should act more like Bayer did in Germany and not store MIC at the plant and just make it when it needed to use it,” said Prof. Gerald E. Beller, chairman of the department of political science at the university, who helped start the local group.

    There are many other issues related to the accident that the chemical safety board wants to talk about, including the amount of overtime Bayer employees had been working before the accident; how poor communications were between the plant and outside emergency crews the night of the accident; and how one of the two men who died, Barry Withrow, had a toxic level of cyanide in his blood that no one has been able to explain.

    But a large part of what the board wants to talk about is the risks posed by the tanks of methyl isocyanate. If the explosion had damaged the smaller above-ground tank in particular, “the consequences of the accident might have been worse,” Mr. Bresland said.

    Lobbyists Outspend Activists (So You Have to Be Loud!)

    The chemical and pharmaceutical industries can outspend concerned moms any day of the week, and they do--so we have to be as loud as we can in supporting efforts like Oregon's toxic chemical bans.
     
     
    Lobbyists spend millions -- and rarely lose in Legislature
     
    By Shane Goldmacher
    sgoldmacher@sacbee.com
    Published: Sunday, Mar. 29, 2009 - 12:00 am | Page 1A

    The first of an occasional series exploring the varied ways in which California lobbyists and their employers press the levers of power.

    Special interests spent a record $553 million lobbying California state government in the past two years.

    For them, it was money well spent.

    Makers of chemical fire- retardants poured in more than $9 million to kill a ban on fire-proofing chemicals in furniture that consumer groups say cause cancer.

    The Morongo Band of Mission Indians used $4.39 million to muscle through a gambling deal to let the tribe add thousands of lucrative new slot machines to its casino.

    The oil industry spent more than $10.5 million to influence the Legislature and state agencies. A 2007 industry association report touted that even in a Democratic-controlled Legislature, "of the 52 bills identified as priorities (in 2007), only three that we opposed were approved by the Legislature."

    Of those three, Gov. Arnold Schwarzenegger vetoed two.

    A Bee analysis of this past two-year session found the 10 highest-spending employers of private lobbyists shelled out a total of more than $70 million working the halls of state government. They rarely lost.

    "You're fighting a mountain of money," said former Assemblywoman Sally Lieber, D-Mountain View. "You have an idea, and they have enormous amounts of money. Who's going to win?"

    Top lobbyists and their employers use the millions to amass armies of advocates to build alliances and cultivate relationships to influence their agenda. They buy meals and gifts and treat policymakers to Disneyland or Kings games. They amp up external pressure by blanketing their targets' constituents with mailers and radio ads.

    Lobby fuels growth industry

    In the past two decades, the amount spent on lobbying in California has increased with each two-year legislative session, rising from $193 million in 1989-90 to more than $550 million last session, state records show.

    The number of groups hiring professional advocates has also grown, from 682 in 1975 to 2,365 at the start of the 2007-08 session.

    With term limits capping how long legislators can serve in the statehouse, the lobby corps is largely the keeper of the Capitol's institutional knowledge.

    Indeed, advocacy groups insist their success comes with earning lawmakers' trust and disseminating accurate information.

    "You're either trustworthy or you're not," said Don Burns, the dean of the lobbying corps, who has represented an array of interests – from pool manufacturers to nuclear waste dumps – in a half-century of advocacy.

    The California Chamber of Commerce's Allan Zaremberg put it this way: "The first thing is we have to ensure that we provide the appropriate level of knowledge and education, because I think that translates eventually into influence."

    Strength found in numbers

    The corps of lobbyists truly is California's third house – and a bigger one at that. Registered lobbyists outnumber lawmakers in Sacramento 8-to-1.

    That ratio allows the richest interests the luxury of swarming the Legislature for key policy battles.

    The California Teachers Association, the No. 4 lobbying spender, and the California Chamber of Commerce, ranked No. 8, each deployed nine full-time lobbyists last session.

    AT&T had three staff lobbyists – and contracts with nine outside firms.

    Frustrated lawmakers taking on a moneyed interest often describe the lobbying ranks aligned against them in military terms.

    "I was outgunned," said Sen. Ellen Corbett, D-San Leandro, who estimated that 30 lobbyists were working against her 2008 bill to ban perfluorinated compounds, or PFCs, from food packaging.

    Her bill passed the Legislature, but Schwarzenegger vetoed it.

    "I would see them in the hallways meeting, outside the chambers, at committee hearings," said Assemblywoman Fiona Ma, D-San Francisco, recalling her 2007 fight with the chemical industry. "They were all over the place."

    Ma's bill – banning phthalates in plastic toys – became law. But it was the only successful chemical ban of a dozen attempted over two years.

    Of lawmakers and Kings

    The sheer number of advocates is no guarantee of success. Lobbying, by nature, is a relationship business.

    While lobbyists are limited to $10 a month in gifts to lawmakers and staff, their employers – the unions, businesses and trade groups paying them – have a much higher limit: $390 per year.

    That is how elected officials regularly enjoy Kings games, meals at posh steakhouses and even tickets to the Rose Bowl free of charge.

    Invariably, representatives of those footing the bill get face time by accompanying policymakers to the events.

    Legislators and interest groups alike insist the gifts have no impact on lawmaking.

    But Don Palmer, a professor who studies ethics and social responsibility, said human nature suggests otherwise.

    "Sociologists call it the 'generalized norm or reciprocity,' " said Palmer, associate dean at the UC Davis Graduate School of Management. "We all learned it in kindergarten: When someone is nice to you or generous to you, then you feel obligated to be nice to them."

    AT&T racked up $250,000 in such giveaways to lawmakers, staff and their families in the past two years. The company declined to be interviewed.

    "(AT&T) will support everybody," said former Senate Republican leader Dick Ackerman. "They will invite everybody to their boxes, both Reeps and Dems, because they just want to try and have relationships with everybody."

    PR blitzes heighten stakes

    When retail lobbying is not enough, well-heeled interests have the resources to mobilize public relations campaigns – or at least threaten to do so – to ratchet up the pressure.

    In early 2007, the Morongo tribe was telling every reporter and lawmaker within earshot of the Capitol that it had allotted $20 million for a PR offensive to win its battle for more slot machines.

    The tribe vowed a statewide TV blitz, 500,000 pieces of direct mail, phone calls and even a door-knocking campaign in the districts of the 10 Democrats on the Assembly's gambling committee.

    It appeared to be a "shock-and-awe"- scale effort to press for its gambling expansion aimed at majority Democrats. One lawmaker called the tribe out for bullying tactics.

    As it turned out, the tribe spent only $3.5 million that quarter, according to financial disclosures filed months later. But the message had been sent – the tribe had the resources to alter the political playing field in Sacramento. Its casino expansion was approved.

    The tribe declined to comment for this story.

    The American Chemistry Council, an industry group, spent $4.7 million in a three-month span in 2008, much of it aimed at a single chemical ban, said Tim Shestek, the council's chief lobbyist.

    Questioning the science behind removing bisphenol-A from plastic products, the industry warned that popular consumer goods would disappear if the ban were approved.

    "We had to do a lot of educational efforts, and some of those educational efforts were expensive," Shestek said of the barrage of mailers, radio and newspaper ads unleashed on districts represented by the Legislature's swing votes.

    The target of the industry's ire, a bill by Democratic Sen. Carole Migden, failed as many lawmakers "took a walk" during the vote, Capitol parlance for making one's self scarce to avoid choosing between a moneyed interest and an unpopular vote.

    Power lies in blocking bills

    The state's most powerful interests don't necessarily get their way with every bill or policy.

    Complex issues involve multiple interests, making it harder for any one group to make a difference.

    The California Hospital Association, for example, ranked as the sixth-largest spender, at $5.9 million. A large portion of that went toward TV ads pressing for lawmakers to pass the tardy state budget last year, said CHA spokeswoman Jan Emerson.

    Hospitals suffered during the impasse because Medi-Cal payments were suspended yet patients continued to receive treatment. The TV ads aired, but the delay dragged on, largely unaffected.

    The real power of the biggest interests is in blocking bills, wielding a de facto veto especially when no moneyed group is lobbying on the other side.

    While the hospitals failed to coax a budget, they succeeded in blocking each of the six bills they opposed.

    "It's so much easier to kill a bill than to pass a bill," said Lenny Goldberg, a consumer lobbyist.

    It's an approach embraced by the California Chamber of Commerce. When the business lobby slaps its "job killer" label on legislation, it is usually a death sentence.

    In 2008 alone, 29 of the 39 "job killers" identified by the chamber died in the Legislature. Schwarzenegger vetoed nine of the remaining 10 that made it to his desk.

    "It's harder to get somebody to vote yes – to make change – than it is to say no," said Zaremberg, the chamber president. "That is just a function of human nature. I don't think it's anything unique to our business."

    Ban bill flames out

    The fire-retardant industry coalition lined up against then-Assemblyman Mark Leno in 2007 after the San Francisco Democrat proposed eliminating brominated and chlorinated flame retardants now used in foam furniture. Leno cited studies saying the compounds cause cancer.

    State records show the industry coalition opposed to his measure spent less than $175,000 in lobbying money in the first half of 2007.

    During that time, Leno's bill sailed out of the Assembly with five votes to spare in the 80-member house.

    Then the industry spent $6.17 million to derail the bill over the next three months. Two new lobbying firms – with seven lobbyists – were hired to work the halls, according to records.

    Glossy mailers with images of children in firefighters' arms warned the bill's passage "could be a deadly mistake." Ads filled newspapers. There was even a small campaign on the airwaves.

    "They threw the kitchen sink at this bill," said Russell Long, vice president of Friends of the Earth and a supporter of the chemical ban.

    Seth Jacobsen, a spokesman for the industry coalition, which now goes by the name Citizens for Fire Safety, said the effort was needed to counter a "hysterical, emotional appeal about how this stuff kills people."

    "In order for us to be successful we have to set the context of the debate," he said. "And for us the context of the debate is about fire safety and not about science."

    The bill died in a September vote of the 40-member state Senate.

    "No money – we got 46 votes" in the Assembly, said Leno, sighing. "Lots of money – we couldn't get 21 votes. That kind of ties it all up."


    Call Shane Goldmacher, Bee Capitol Bureau, (916) 326-5544. • In Monday's Bee: The role that campaigns – and campaign contributions – play in the lawmaking process.

    * * *

    http://www.oregonlive.com/news/index.ssf/2009/03/could_your_recliner_be_dangero.html

    Oregon Legislature considers toxics in consumer products

    by Scott Learn, The Oregonian
    Sunday March 29, 2009, 9:31 PM

    Should Oregon have more say over the chemicals used to make your baby's bottle, her toys, your dishwasher detergent and your sofa?

    The Legislature gets to answer that question this session, with a dozen bills targeting the chemical hazards of everyday life.

    Potential toxics on the hit list range from fire retardants in upholstered furniture to phosphates in dishwasher soap to plastic additives in baby bottles and soft plastic toys.

    The chemicals are commonplace. They're found at low levels almost everywhere, including human blood and urine, umbilical cords, breast milk, drinking water, birds and fish. They're also part and parcel of our consumer economy.

    That's what makes them so tough to legislate.

    Activists concede that, in most cases, the science isn't lock-tight that the low doses harm people or the environment. The amounts found in blood and drinking water are almost always well below levels the federal government considers unsafe.

    But the crammed legislative agenda comes as more studies raise concerns about potential toxics in consumer products, particularly the effects on infants and children.

    Given the federal government's go-slow history with mass-produced chemicals -- including lead, the now-banned pesticide DDT and PCBs, a mostly banned industrial insulator -- a cautious state approach makes sense, said Renee Hackenmiller-Paradis, environmental health director for the Oregon Environmental Council.

    "In the long run, that's going to save a lot of suffering and a lot of dollars," she said.

    The drive to crack down on chemicals faces a big political obstacle, said Terry Witt, executive director of Oregonians for Food and Shelter: the down economy.

    "It's a double whammy," he said. "You're requiring more of agencies that have less money, and you're applying more regulation and expense on business."

    The most sweeping bill, House Bill 2141, would expand the definition of hazardous substances to include products containing chemicals with long-term health effects. It would require labeling standards that can include the word "caution" or "warning." And it would give the state authority to ban products.

    Two other bills target chemicals in products designed for children under 12. One, HB2792, would require the Department of Human Services to identify priority chemicals and allow DHS to require manufacturers of children's products to use safer alternatives, if available.

    The second, HB2367, would bar sales of children's products with more than trace amounts of the plastic additives bisphenol-A and six types of phthalates. Most famously, that includes baby bottles containing bisphenol-A, the latest subject of dueling health claims and studies.

    Rep. Paul Holvey, D-Eugene, chairman of the House consumer protection committee, said the bills are not about "banning every chemical under the sun." State regulators can draw on existing studies and research.

    "Just like a doctor would do, we should have the ability to look at peer-reviewed studies and ask, 'Is this something we should be concerned about?'" Holvey said.

    Industry groups lining up against the bills included the American Chemistry Council, Procter & Gamble, the Oregon Metals Industry Council and the International Bottled Water Association.

    Rep. Jim Weidner, R-Yamhill, vice chairman of the consumer protection committee, said it makes more sense to let federal agencies take the lead.

    Many manufacturers have global reach, said Tim Shestek, director of state affairs for the chemistry council, making it tough to comply with a potpourri of state policies.

    The U.S. Environmental Protection Agency, the Food and Drug Administration and other agencies are studying consumer product chemicals now, and Congress is debating whether to revamp U.S. toxics control.

    "These are complex decisions that involve groups of scientists and lots of detailed information and research," Shestek said.

    Last summer, Congress cut allowable levels of lead and six types of phthalates (pronounced THAL-ates), chemicals used to bind fragrances in shampoo and lotions and soften plastic in toys and lunchboxes.

    Other Oregon bills would require manufacturer-funded recycling of rechargeable batteries and mercury-containing fluorescent bulbs, and pressure schools to use green cleaning products and fewer pesticides.

    So far, the legislation that's moved farthest is Senate Bill 596, which would ban most uses of the fire retardant decabrominated diphenyl ether, classified as a possible human carcinogen, by 2011. It passed the Senate last week.

    Deca-BDE is widely used in consumer products, including mattresses, upholstery and televisions. But Washington and Maine, which are already phasing out the chemical, concluded there are safer substitutes.

    Like many consumer chemicals, the fire retardant gets into the environment and people via airborne dust and sewage treatment plants. Like DDT and PCBs, it lasts for decades and accumulates in aquatic life, said Travis Williams, Willamette Riverkeeper's executive director.

    Private and public land owners in Portland Harbor, a federal Superfund site on the Willamette, are likely to spend tens of millions cleaning up PCBs and DDT from river sediment.

    "It's hard to even fathom that this could happen again," Williams said.

    Manufacturers are fighting the Deca-BDE ban, arguing that the evidence of harm is minimal. The chemistry council is fighting the ban on bisphenol-A, or BPA, a potential reproductive toxic.

    Last year, the council successfully beat back a BPA ban in California, helped by an FDA study that said infant exposure to BPA from baby bottles and other food containers is 2,000 times lower than levels of concern.

    But a later report issued by the National Toxicology Program cited "some concern" for brain and behavioral effects in fetuses, infants and children. Canada banned BPA from baby bottles. Europe decided not to.

    Many retailers and manufacturers are ahead of lawmakers. Wal-Mart and Toys "R" Us decided last year to stop selling baby bottles made with BPA.

    Oregon's Department of Environmental Quality is also setting a list of "priority persistent pollutants" to reduce water pollution.

    The draft list includes 175 potential toxics, from pesticides to industrial metals.

    Gail Shibley, who runs the state's environmental public health office, said her group would piggyback on that initiative and others.

    "We need to keep human health concerns foremost," she said. "We are living in a soup of these exposures, from before we're born to our last breath."

    -- Scott Learn; scottlearn@news.oregonian.com

    Targeting chemical hazards

    Upholstered furniture, mattresses, televisions: Can contain the fire retardant decabrominated diphenyl ether, a possible human carcinogen. Proposal: Largely ban by 2011.

    Plastic baby bottles, sippy cups: Can contain bisphenol-A, which the National Toxicology Programs says raise "some concern" for health effects in fetuses, infants and children. Proposal: Bar sale of consumer products for children under 12 containing BPA.

    Soft plastic toys, baby lotion, baby shampoo: Can contain phthalates, some of which have shown reproductive toxicity in animal studies. Proposal: Bar sale of consumer products for children under 12 containing some phthalates.

    Automatic dishwasher detergent: Can contain phosphorous, which causes oxygen-depleting algal blooms in rivers. Proposal: Bar dishwasher detergent with more than minimal amounts of phosphorous.

    Fluorescent bulbs: Contain small amounts of mercury, a neurotoxin. Proposal: Require manufacturers to pay for recycling.

    Rechargeable batteries: Contain toxic heavy metals, a persistent water pollutant. Proposal: Require manufacturers to pay for recycling.

    Paint: Can contain a variety of chemicals, including volatile organic compounds, an indoor and outdoor air pollution. Proposal: Initiate a pilot paint recycling program.

    Cleaning products (e.g. drain cleaners, most oven cleaners, some toilet bowl cleaners, some rust removers; solvent-based cleaning products, such as spot removers, degreasers, and some furniture polishes and metal polishes): Can contain ingredients that irritate lungs, skin and eyes; can accidentally poison children. Proposed action: Require schools to use green cleaning products by 2011, unless not "economically feasible."

    Pesticides: Wide variety of human and environmental effects. Proposals: Require schools to minimize pesticide use; require foresters and farmers within a quarter mile of a school to provide written notice before aerial spraying.

    -- Scott Learn

    26 mars

    APA Says Bye-Bye to Big Pharma's Dinners

    ...or some of them, at least. Some integrity! At last!
     
     

    U.S. psychiatrists to end drug company seminars

    Wed Mar 25, 2009 2:41pm EDT
     

    By Julie Steenhuysen

    CHICAGO (Reuters) - The American Psychiatric Association said on Wednesday it will end medical education seminars and meals sponsored by drug companies at its annual meetings to reduce chances for financial conflicts of interest.

    The group, which represents 38,000 doctors, is among the first to say no to the drug-company sponsored seminars at its meetings, which many critics say blur the line between education and advertising.

    Psychiatrists have been at the front of a controversy over conflicts of interest following accusations last year by Republican U.S. Senator Charles Grassley that prominent Harvard University psychiatrist Dr. Joseph Biederman and others failed to fully disclose payments from drug companies.

    Psychiatric drugs represent billions of dollars in global sales. Last July, Grassley asked the APA to provide information about its financial ties with the drug industry.

    Dr. Nada Stotland, president of the APA, said the group began working on the issue a year ago, long before it became the subject of a probe.

    "We're not blaming the pharmaceutical companies for anything and we're not severing all relations with them," Stotland said in a telephone interview.

    She said drug companies paid the group in order to sponsor glitzy education symposiums put on by prominent doctors during its annual meetings, typically over breakfast or dinner.

    And while Stotland said the group took care to avoid biased reporting at these presentations, she said the notion of mixing something that is basically a gift with education "wasn't the healthiest mixture."

    The move includes the elimination of industry-supplied meals that were provided during the symposiums.

    "There is a perception that accepting meals provided by pharmaceutical companies may have a subtle influence on doctors' prescribing habits," Dr. James Scully, APA's medical director and chief executive officer, said in a statement.

    "While industry-funded meals used to be normal operating procedure at medical meetings, a sea change is currently underway in how we manage industry relationships," he said.

    "What was acceptable five years ago isn't necessarily acceptable today."

    Earlier this year, many drug makers said they would stop giving out small gifts such as pens and flash drives as part of new voluntary guidelines from the Pharmaceutical Research and Manufacturers of America, an industry group in Washington.

    The group's 2002 code already bans more costly gifts like trips to resorts, and calls for companies that pay for medical education at conferences to leave the content to outside experts.

    (Editing by Will Dunham)

    Global Warming Isn't Real

    Pollution is real. Mercury from coal-fired power plants is real. PCBs released into the waterways are real. Global warming is not.
     
     
    The Civil Heretic
     
    By NICHOLAS DAWIDOFF
    Published: March 25, 2009

    FOR MORE THAN HALF A CENTURY the eminent physicist Freeman Dyson has quietly resided in Prince­ton, N.J., on the wooded former farmland that is home to his employer, the Institute for Advanced Study, this country’s most rarefied community of scholars. Lately, however, since coming “out of the closet as far as global warming is concerned,” as Dyson sometimes puts it, there has been noise all around him. Chat rooms, Web threads, editors’ letter boxes and Dyson’s own e-mail queue resonate with a thermal current of invective in which Dyson has discovered himself variously described as “a pompous twit,” “a blowhard,” “a cesspool of misinformation,” “an old coot riding into the sunset” and, perhaps inevitably, “a mad scientist.” Dyson had proposed that whatever inflammations the climate was experiencing might be a good thing because carbon dioxide helps plants of all kinds grow. Then he added the caveat that if CO2 levels soared too high, they could be soothed by the mass cultivation of specially bred “carbon-eating trees,” whereupon the University of Chicago law professor Eric Posner looked through the thick grove of honorary degrees Dyson has been awarded — there are 21 from universities like Georgetown, Princeton and Oxford — and suggested that “perhaps trees can also be designed so that they can give directions to lost hikers.” Dyson’s son, George, a technology historian, says his father’s views have cooled friendships, while many others have concluded that time has cost Dyson something else. There is the suspicion that, at age 85, a great scientist of the 20th century is no longer just far out, he is far gone — out of his beautiful mind.

    But in the considered opinion of the neurologist Oliver Sacks, Dyson’s friend and fellow English expatriate, this is far from the case. “His mind is still so open and flexible,” Sacks says. Which makes Dyson something far more formidable than just the latest peevish right-wing climate-change denier. Dyson is a scientist whose intelligence is revered by other scientists — William Press, former deputy director of the Los Alamos National Laboratory and now a professor of computer science at the University of Texas, calls him “infinitely smart.” Dyson — a mathematics prodigy who came to this country at 23 and right away contributed seminal work to physics by unifying quantum and electrodynamic theory — not only did path-breaking science of his own; he also witnessed the development of modern physics, thinking alongside most of the luminous figures of the age, including Einstein, Richard Feynman, Niels Bohr, Enrico Fermi, Hans Bethe, Edward Teller, J. Robert Oppenheimer and Edward Witten, the “high priest of string theory” whose office at the institute is just across the hall from Dyson’s. Yet instead of hewing to that fundamental field, Dyson chose to pursue broader and more unusual pursuits than most physicists — and has lived a more original life.

    Among Dyson’s gifts is interpretive clarity, a penetrating ability to grasp the method and significance of what many kinds of scientists do. His thoughts about how science works appear in a series of lucid, elegant books for nonspecialists that have made him a trusted arbiter of ideas ranging far beyond physics. Dyson has written more than a dozen books, including “Origins of Life” (1999), which synthesizes recent discoveries by biologists and geologists into an evaluation of the double-origin hypothesis, the possibility that life began twice; “Disturbing the Universe” (1979) tries among other things to reconcile science and humanity. “Weapons and Hope” (1984) is his meditation on the meaning and danger of nuclear weapons that won a National Book Critics Circle Award. Dyson’s books display such masterly control of complex matters that smart young people read him and want to be scientists; older citizens finish his books and feel smart.

    Yet even while probing and sifting, Dyson is always whimsically gazing into the beyond. As a boy he sketched plans for English rocket ships that could explore the stars, and then, in midlife, he helped design an American spacecraft to be powered by exploding atomic bombs — a secret Air Force project known as Orion. Dyson remains an armchair astronaut who speculates with glee about the coming of cheap space travel, when families can leave an overcrowded earth to homestead on asteroids and comets, swooping around the universe via solar sail craft. Dyson is convinced that our current “age of computers” will soon give way to “the age of domesticated biotechnology.” Bio-tech, he writes in his book, “Infinite in All Directions” (1988), “offers us the chance to imitate nature’s speed and flexibility,” and he imagines the furniture and art that people will “grow” for themselves, the pet dinosaurs they will “grow” for their children, along with an idiosyncratic menagerie of genetically engineered cousins of the carbon-eating tree: termites to consume derelict automobiles, a potato capable of flourishing on the dry red surfaces of Mars, a collision-avoiding car.

    These ideas attract derision similar to Dyson’s essays on climate change, but he is an undeterred octogenarian futurist. “I don’t think of myself predicting things,” he says. “I’m expressing possibilities. Things that could happen. To a large extent it’s a question of how badly people want them to. The purpose of thinking about the future is not to predict it but to raise people’s hopes.” Formed in a heretical and broad-thinking tradition of British public intellectuals, Dyson left behind a brooding England still stricken by two bloody world wars to become an optimistic American immigrant with tremendous faith in the creative imagination’s ability to invent technologies that would overcome any predicament. And according to the physicist and former Caltech president Marvin Goldberger, Dyson is himself the living embodiment of that kind of ingenuity. “You point Freeman at a problem and he’ll solve it,” Goldberger says. “He’s extraordinarily powerful.” Dyson seems to see the world as an interdisciplinary set of problems out there for him to evaluate. Climate change is the big scientific issue of our time, so naturally he finds it irresistible. But to Dyson this is really only one more charged conundrum attracting his interest just as nuclear weapons and rural poverty have. That is to say, he is a great problem-solver who is not convinced that climate change is a great problem.

    Dyson is well aware that “most consider me wrong about global warming.” That educated Americans tend to agree with the conclusion about global warming reached earlier this month at the International Scientific Conference on Climate Change in Copenhagen (“inaction is inexcusable”) only increases Dyson’s resistance. Dyson may be an Obama-loving, Bush-loathing liberal who has spent his life opposing American wars and fighting for the protection of natural resources, but he brooks no ideology and has a withering aversion to scientific consensus. The Nobel physics laureate Steven Weinberg admires Dyson’s physics — he says he thinks the Nobel committee fleeced him by not awarding his work on quantum electrodynamics with the prize — but Weinberg parts ways with his sensibility: “I have the sense that when consensus is forming like ice hardening on a lake, Dyson will do his best to chip at the ice.”

    Dyson says he doesn’t want his legacy to be defined by climate change, but his dissension from the orthodoxy of global warming is significant because of his stature and his devotion to the integrity of science. Dyson has said he believes that the truths of science are so profoundly concealed that the only thing we can really be sure of is that much of what we expect to happen won’t come to pass. In “Infinite in All Directions,” he writes that nature’s laws “make the universe as interesting as possible.” This also happens to be a fine description of Dyson’s own relationship to science. In the words of Avishai Margalit, a philosopher at the Institute for Advanced Study, “He’s a consistent reminder of another possibility.” When Dyson joins the public conversation about climate change by expressing concern about the “enormous gaps in our knowledge, the sparseness of our observations and the superficiality of our theories,” these reservations come from a place of experience. Whatever else he is, Dyson is the good scientist; he asks the hard questions. He could also be a lonely prophet. Or, as he acknowledges, he could be dead wrong.

    IT WAS FOUR YEARS AGO that Dyson began publicly stating his doubts about climate change. Speaking at the Frederick S. Pardee Center for the Study of the Longer-Range Future at Boston University, Dyson announced that “all the fuss about global warming is grossly exaggerated.” Since then he has only heated up his misgivings, declaring in a 2007 interview with Salon.com that “the fact that the climate is getting warmer doesn’t scare me at all” and writing in an essay for The New York Review of Books, the left-leaning publication that is to gravitas what the Beagle was to Darwin, that climate change has become an “obsession” — the primary article of faith for “a worldwide secular religion” known as environmentalism. Among those he considers true believers, Dyson has been particularly dismissive of Al Gore, whom Dyson calls climate change’s “chief propagandist,” and James Hansen, the head of the NASA Goddard Institute for Space Studies in New York and an adviser to Gore’s film, “An Inconvenient Truth.” Dyson accuses them of relying too heavily on computer-generated climate models that foresee a Grand Guignol of imminent world devastation as icecaps melt, oceans rise and storms and plagues sweep the earth, and he blames the pair’s “lousy science” for “distracting public attention” from “more serious and more immediate dangers to the planet.”

    A particularly distressed member of that public was Dyson’s own wife, Imme, who, after seeing the film in a local theater with Dyson when it was released in 2006, looked at her husband out on the sidewalk and, with visions of drowning polar bears still in her eyes, reproached him: “Everything you told me is wrong!” she cried.

    “The polar bears will be fine,” he assured her.

    Not long ago Dyson sat in his institute office, a chamber so neat it reminds Dyson’s friend, the writer John McPhee, of a Japanese living room. On shelves beside Dyson were books about stellar evolution, viruses, thermodynamics and terrorism. “The climate-studies people who work with models always tend to overestimate their models,” Dyson was saying. “They come to believe models are real and forget they are only models.” Dyson speaks in calm, clear tones that carry simultaneous evidence of his English childhood, the move to the United States after completing his university studies at Cambridge and more than 50 years of marriage to the German-born Imme, but his opinions can be barbed, especially when a conversation turns to climate change. Climate models, he says, take into account atmospheric motion and water levels but have no feeling for the chemistry and biology of sky, soil and trees. “The biologists have essentially been pushed aside,” he continues. “Al Gore’s just an opportunist. The person who is really responsible for this overestimate of global warming is Jim Hansen. He consistently exaggerates all the dangers.”

    Dyson agrees with the prevailing view that there are rapidly rising carbon-dioxide levels in the atmosphere caused by human activity. To the planet, he suggests, the rising carbon may well be a MacGuffin, a striking yet ultimately benign occurrence in what Dyson says is still “a relatively cool period in the earth’s history.” The warming, he says, is not global but local, “making cold places warmer rather than making hot places hotter.” Far from expecting any drastic harmful consequences from these increased temperatures, he says the carbon may well be salubrious — a sign that “the climate is actually improving rather than getting worse,” because carbon acts as an ideal fertilizer promoting forest growth and crop yields. “Most of the evolution of life occurred on a planet substantially warmer than it is now,” he contends, “and substantially richer in carbon dioxide.” Dyson calls ocean acidification, which many scientists say is destroying the saltwater food chain, a genuine but probably exaggerated problem. Sea levels, he says, are rising steadily, but why this is and what dangers it might portend “cannot be predicted until we know much more about its causes.”

    For Hansen, the dark agent of the looming environmental apocalypse is carbon dioxide contained in coal smoke. Coal, he has written, “is the single greatest threat to civilization and all life on our planet.” Hansen has referred to railroad cars transporting coal as “death trains.” Dyson, on the other hand, told me in conversations and e-mail messages that “Jim Hansen’s crusade against coal overstates the harm carbon dioxide can do.” Dyson well remembers the lethal black London coal fog of his youth when, after a day of visiting the city, he would return to his hometown of Winchester with his white shirt collar turned black. Coal, Dyson says, contains “real pollutants” like soot, sulphur and nitrogen oxides, “really nasty stuff that makes people sick and looks ugly.” These are “rightly considered a moral evil,” he says, but they “can be reduced to low levels by scrubbers at an affordable cost.” He says Hansen “exploits” the toxic elements of burning coal as a way of condemning the carbon dioxide it releases, “which cannot be reduced at an affordable cost, but does not do any substantial harm.”

    Science is not a matter of opinion; it is a question of data. Climate change is an issue for which Dyson is asking for more evidence, and leading climate scientists are replying by saying if we wait for sufficient proof to satisfy you, it may be too late. That is the position of a more moderate expert on climate change, William Chameides, dean of the Nicholas School of the Environment and Earth Sciences at Duke University, who says, “I don’t think it’s time to panic,” but contends that, because of global warming, “more sea-level rise is inevitable and will displace millions; melting high-altitude glaciers will threaten the food supplies for perhaps a billion or more; and ocean acidification could undermine the food supply of another billion or so.” Dyson strongly disagrees with each of these points, and there follows, as you move back and forth between the two positions, claims and counterclaims, a dense thicket of mitigating scientific indicators that all have the timbre of truth and the ring of potential plausibility. One of Dyson’s more significant surmises is that a warming climate could be forestalling a new ice age. Is he wrong? No one can say for sure. Beyond the specific points of factual dispute, Dyson has said that it all boils down to “a deeper disagreement about values” between those who think “nature knows best” and that “any gross human disruption of the natural environment is evil,” and “humanists,” like himself, who contend that protecting the existing biosphere is not as important as fighting more repugnant evils like war, poverty and unemployment.

    Embedded in all of Dyson’s strong opinions about public policy is a dual spirit of social activism and uneasiness about class dating all the way back to Winchester, where he was raised in the 1920s and ’30s by his father, George Dyson, the son of a Yorkshire blacksmith. George was the music instructor at Winchester College, an old and prestigious secondary school, and a composer. Dyson’s mother, Mildred Atkey, came from a more prosperous Wimbledon family that had its own tennis court. Together they raised Dyson and his sister, Alice, in what Dyson calls a “watered-down Church of England Christianity” that regarded religion as a guide to living rather than any system of belief. The emphasis on tolerance, charity and community — and the free time afforded by the luxury of four servants — led Mildred to organize a club for teenage girls and a birth-control clinic. These institutions meshed uneasily with her patrician Victorian sensibilities. The girls were never, Dyson says, “considered equals,” and Mildred told him with amusement about the young mother who walked in carrying a red-headed infant. “What a beautiful baby,” Mildred reported saying. “Does he take after his father?”

    “Oh, I couldn’t tell you, Mum,” came the reply. “He kept his hat on.”

    Winchester is a medieval town in which, Dyson writes, he felt that everyone was looking backward, mourning all the young men lost to one world war while silently anticipating his own generation’s impending demise. He renounced the nostalgia, the servants, the hard-line social castes. But what he liked about growing up in England was the landscape. The country’s successful alteration of wilderness and swamp had created a completely new green ecology, allowing plants, animals and humans to thrive in “a community of species.” Dyson has always been strongly opposed to the idea that there is any such thing as an optimal ecosystem — “life is always changing” — and he abhors the notion that men and women are something apart from nature, that “we must apologize for being human.” Humans, he says, have a duty to restructure nature for their survival.

    All this may explain why the same man could write “we live on a shrinking and vulnerable planet which our lack of foresight is rapidly turning into a slum” and yet gently chide the sort of Americans who march against coal in Washington. Dyson has great affection for coal and for one big reason: It is so inexpensive that most of the world can afford it. “There’s a lot of truth to the statement Greens are people who never had to worry about their grocery bills,” he says. (“Many of these people are my friends,” he will also tell you.) To Dyson, “the move of the populations of China and India from poverty to middle-class prosperity should be the great historic achievement of the century. Without coal it cannot happen.” That said, Dyson sees coal as the interim kindling of progress. In “roughly 50 years,” he predicts, solar energy will become cheap and abundant, and “there are many good reasons for preferring it to coal.”

    ...

    Dyson says it’s only principle that leads him to question global warming: “According to the global-warming people, I say what I say because I’m paid by the oil industry. Of course I’m not, but that’s part of their rhetoric. If you doubt it, you’re a bad person, a tool of the oil or coal industry.” Global warming, he added, “has become a party line.”

    What may trouble Dyson most about climate change are the experts. Experts are, he thinks, too often crippled by the conventional wisdom they create, leading to the belief that “they know it all.” The men he most admires tend to be what he calls “amateurs,” inventive spirits of uncredentialed brilliance like Bernhard Schmidt, an eccentric one-armed alcoholic telescope-lens designer; Milton Humason, a janitor at Mount Wilson Observatory in California whose native scientific aptitude was such that he was promoted to staff astronomer; and especially Darwin, who, Dyson says, “was really an amateur and beat the professionals at their own game.” It’s a point of pride with Dyson that in 1951 he became a member of the physics faculty at Cornell and then, two years later, moved on to the Institute for Advanced Study, where he became an influential man, a pragmatist providing solutions to the military and Congress, and also the 2000 winner of the $1 million Templeton Prize for broadening the understanding of science and religion, an award previously given to Mother Teresa and Aleksandr Solzhenitsyn — all without ever earning a Ph.D. Dyson may, in fact, be the ultimate outsider-insider, “the world’s most civil heretic,” as the classical composer Paul Moravec, the artistic consultant at the institute, says of him.

    Climate-change specialists often speak of global warming as a matter of moral conscience. Dyson says he thinks they sound presumptuous. As he warned that day four years ago at Boston University, the history of science is filled with those “who make confident predictions about the future and end up believing their predictions,” and he cites examples of things people anticipated to the point of terrified certainty that never actually occurred, ranging from hellfire, to Hitler’s atomic bomb, to the Y2K millennium bug. “It’s always possible Hansen could turn out to be right,” he says of the climate scientist. “If what he says were obviously wrong, he wouldn’t have achieved what he has. But Hansen has turned his science into ideology. He’s a very persuasive fellow and has the air of knowing everything. He has all the credentials. I have none. I don’t have a Ph.D. He’s published hundreds of papers on climate. I haven’t. By the public standard he’s qualified to talk and I’m not. But I do because I think I’m right. I think I have a broad view of the subject, which Hansen does not. I think it’s true my career doesn’t depend on it, whereas his does. I never claim to be an expert on climate. I think it’s more a matter of judgement than knowledge.”

    Reached by telephone, Hansen sounds annoyed as he says, “There are bigger fish to fry than Freeman Dyson,” who “doesn’t know what he’s talking about.” In an e-mail message, he adds that his own concern about global warming is not based only on models, and that while he respects the “open-mindedness” of Dyson, “if he is going to wander into something with major consequences for humanity and other life on the planet, then he should first do his homework — which he obviously has not done on global warming.”

    When Dyson hears about this, he looks, if possible, like a person taking the longer view. He is a short, sinewy man with strawlike filaments of excitable gray hair that make him resemble an upside-down broom. Every day he dresses with the same frowzy Oxbridge formality in L. L. Bean khaki trousers (his daughter Mia is a minister in Maine), a tweed sport coat, a necktie (most often one made for him, he says, by another daughter, Emily, many years ago “in the age of primary colors”) and wool sweater-vests. On cold days he wears a second vest, one right over the other, and the effect is like a window with two sets of curtains. His smile is the real window, a delighted beam that appears to float free from his face, strangely dynamic with its electric ears and quantum nose, and his laugh is so hearty it shakes him. The smile and laughter have the effect of softening Dyson’s formality, transforming him into a sage and friendly elf, and also reminding those he talks with that he has spent a lifetime immersed in efforts to find what he considers humane solutions to dire problems, whose controversial gloss never seems to agitate him. His eyes are murky gray, and whatever he’s thinking beyond what he says, the eyes never betray.

    ...

    This was an early indication of Dyson’s growing interest in what one day would be called climate studies. In 1976, Dyson began making regular trips to the Institute for Energy Analysis in Oak Ridge, Tenn., where the director, Alvin Weinberg, was in the business of investigating alternative sources of power. Charles David Keeling’s pioneering measurements at Mauna Loa, Hawaii, showed rapidly increasing carbon-dioxide levels in the atmosphere; and in Tennessee, Dyson joined a group of meteorologists and biologists trying to understand the effects of carbon on the Earth and air. He was now becoming a climate expert. Eventually Dyson published a paper titled “Can We Control the Carbon Dioxide in the Atmosphere?” His answer was yes, and he added that any emergency could be temporarily thwarted with a “carbon bank” of “fast-growing trees.” He calculated how many trees it would take to remove all carbon from the atmosphere. The number, he says, was a trillion, which was “in principle quite feasible.” Dyson says the paper is “what I’d like people to judge me by. I still think everything it says is true.”

    Eventually he would embrace another idea: the notorious carbon-eating trees, which would be genetically engineered to absorb more carbon than normal trees. Of them, he admits: “I suppose it sounds like science fiction. Genetic engineering is politically unpopular in the moment.”

    In the 1970s, Dyson participated in other climate studies conducted by Jason, a small government-financed group of the country’s finest scientists, whose members gather each summer near San Diego to work on (often) classified (usually) scientific dilemmas of (frequently) military interest to the government. Dyson has, as he admits, a restless nature, and by the time many scientists were thinking about climate, Dyson was on to other problems. Often on his mind were proposals submitted by the government to Jason. “Mainly we kill stupid projects,” he says.

    Some scientists refuse military work on the grounds that involvement in killing is sin. Dyson was opposed to the wars in Vietnam and Iraq, but not to generals. He had seen in England how a military more enlightened by quantitative analysis could have better protected its men and saved the lives of civilians. “I always felt the worse the situation was, the more important it was to keep talking to the military,” he says. Over the years he says he pushed the rejection of the idea of dropping atomic bombs on North Vietnam and solved problems in adaptive optics for telescopes. Lately he has been “trying to help the intelligence people be aware of what the bad guys may be doing with biology.” Dyson thinks of himself as “fighting for peace,” and Joel Lebowitz, a Rutgers physicist who has known Dyson for 50 years, says Dyson lives up to that: “He works for Jason and he’s out there demonstrating against the Iraq war.”

    Lately Dyson has been lamenting that he and Imme “don’t see so much of each other. We’re always rushing around.” But one evening last month they sat down in a living room filled with Imme’s running trophies and photographs of their children to watch “An Inconvenient Truth” again. There was a print of Einstein above the television. And then there was Al Gore below him, telling of the late Roger Revelle, a Harvard scientist who first alerted the undergraduate Gore to how severe the climate’s problems would become. Gore warned of the melting snows of Kilimanjaro, the vanishing glaciers of Peru and “off the charts” carbon levels in the air. “The so-called skeptics” say this “seems perfectly O.K.,” Gore said, and Imme looked at her husband. She is even slighter than he is, a pretty wood sprite in running shoes. “How far do you allow the oceans to rise before you say, This is no good?” she asked Dyson.

    “When I see clear evidence of harm,” he said.

    “Then it’s too late,” she replied. “Shouldn’t we not add to what nature’s doing?”

    “The costs of what Gore tells us to do would be extremely large,” Dyson said. “By restricting CO2 you make life more expensive and hurt the poor. I’m concerned about the Chinese.”

    “They’re the biggest polluters,” Imme replied.

    “They’re also changing their standard of living the most, going from poor to middle class. To me that’s very precious.”

    The film continued with Gore predicting violent hurricanes, typhoons and tornados. “How in God’s name could that happen here?” Gore said, talking about Hurricane Katrina. “Nature’s been going crazy.”

    “That is of course just nonsense,” Dyson said calmly. “With Katrina, all the damage was due to the fact that nobody had taken the trouble to build adequate dikes. To point to Katrina and make any clear connection to global warming is very misleading.”

    Now came Arctic scenes, with Gore telling of disappearing ice, drunken trees and drowning polar bears. “Most of the time in history the Arctic has been free of ice,” Dyson said. “A year ago when we went to Greenland where warming is the strongest, the people loved it.”

    “They were so proud,” Imme agreed. “They could grow their own cabbage.”

    The film ended. “I think Gore does a brilliant job,” Dyson said. “For most people I’d think this would be quite effective. But I knew Roger Revelle. He was definitely a skeptic. He’s not alive to defend himself.”

    “All my friends say how smart and farsighted Al Gore is,” she said.

    “He certainly is a good preacher,” Dyson replied. “Forty years ago it was fashionable to worry about the coming ice age. Better to attack the real problems like the extinction of species and overfishing. There are so many practical measures we could take.”

    “I’m still perfectly happy if you buy me a Prius!” Imme said.

    “It’s toys for the rich,” her husband smiled, and then they were arguing about windmills.

    Urge Your Congressman to Support Ted Kennedy's Antibiotics Bill

    The CEO of Reuters is on the Board of Directors at Merck, so don't expect objectivity from this article. All you really need to know is that 70 percent of all antibiotics sold in the US are used to treat healthy animals prophylactically--because the animals are kept in unsanitary conditions. We don't need more antibiotic-resistant microbes, and we don't need to make it easy for megafarmers to mistreat livestock. This bill needs to become law.
     
     

    Antibiotic ban on livestock may hurt food safety

    Farm group opposes bill to stop use of drugs in healthy animals

     

    updated 11:50 a.m. ET, Tues., March. 24, 2009

    WASHINGTON - A bill that would ban the nontherapeutic use of antibiotics in animals would hurt the health of livestock and poultry while compromising efforts to protect the safety of the country's food supply, the leader of the largest U.S. farm group said on Tuesday.

    Bob Stallman, president of the 6 million-member American Farm Bureau Federation, said in a letter to Congress that its members "carefully, judiciously and according to label instructions" use antibiotics to treat, prevent and control disease in animals.

    "Antibiotic use in animals does not pose a serious public health threat," said Stallman, who urged lawmakers to oppose the bill. "Restricting access to these important tools will jeopardize animal health and compromise our ability to contribute to public health through food safety" he added.

    Industry groups that oppose the ban contend animal deaths would go up, producer costs would rise, meat output would drop and consumers would see prices climb. They contend there is no evidence that a public health threat has occurred because of the use of antibiotics in animals.

    Introduced in the House of Representatives by Louise Slaughter and in the Senate by Edward Kennedy, the legislation, would ban the use of antibiotics important to human health from being used on cattle, hogs, sheep and poultry unless animals are ill.

    Drug manufacturers would be allowed to sell antibiotics for nonhuman uses if they can show there is no danger to public health from microbes developing drug resistances.

    Proponents of the ban say antibiotics are given to healthy animals over a long period of time to compensate for unsanitary and crowded conditions, and to promote weight gain, rather than to combat illness.

    The concern is that the overuse of antibiotics in animals leads to new strains of antibiotic-resistant bacteria. As a result, people may be at risk of becoming sick by handling, eating meat or coming in contact with animals that have an antibiotic-resistant disease.

    An estimated 70 percent of all antibiotics sold in the United States go toward healthy livestock, according to a study by the Union of Concerned Scientists.

    * * *

    and in other bad news...

    http://www.msnbc.msn.com/id/29665562/

    [Keep in mind a few things: E. coli is not a disease; it's a bacterium important to digestion. Clean slaughtering conditions would take care of all bacterial contamination, as would cooking beef until it's well done.]

    Nation’s first E. coli vaccine for cattle approved

    USDA OK’s new weapon against disease that's potentially fatal to people

    updated 8:15 p.m. ET, Thurs., March. 12, 2009

    MINNEAPOLIS - A Minnesota company has won federal approval to become the first in the U.S. to market an E. coli vaccine for cattle, a new weapon against a foodborne disease that can cause serious illness in people and even death.

    Epitopix LLC was given a conditional license from the U.S. Department of Agriculture to sell its vaccine.

    Nayyera Haq, a USDA spokeswoman, called it "an important step toward improving food safety in this country," and a major beef group agreed.

    "It really is a major milestone for our industry," Michelle Rossman, director of beef safety research for the National Cattlemen's Beef Association, said Thursday.

    Most E. coli bacteria are harmless but one kind, known as O157, sickens an estimated 70,000 people in the U.S. every year, according to the Centers for Disease Control and Prevention. Most people recover in a few days, but some get serious complications such as kidney failure. Contaminated beef is a common source of infection and has led to several big meat recalls in recent years.

    How the vaccine works
    James Sandstrom, general manager of Willmar-based Epitopix, said the vaccine works by preventing E. coli O157 present in cows' intestines from absorbing iron. The company's technology takes the proteins that the bacteria uses to absorb iron from the host animal, and injects them back into cattle to generate an immune response against those proteins. Without the proteins, the bacteria can't absorb the iron and dies.

    With fewer bacteria in the cows' intestines, the risk is reduced that the bacteria will contaminate the carcass at slaughter.

    Sandstrom said the vaccine will enter commercial use this month, but it will be several months before it's widely available. He said some major packers and producers will be the first to use it, but declined to name them, saying they don't want their names associated with E. coli even for research.

    It's not clear yet how widely the industry will embrace the vaccine.

    "That's the $64 million question," Sandstrom said.

    E. coli O157 doesn't make cattle sick, so producers who already face slim profit margins may need incentives to use it on their animals. Sandstrom said privately owned Epitopix hasn't set a price for the vaccine yet, but is hoping incentives will come from packers and retailers who would profit from being able to offer consumers safer beef.

    A Canadian company that makes an E. coli vaccine for cattle sells it there for $7 U.S. ($9 Canadian) per cow.

    A spokesman for Tyson Foods Inc., one of the nation's largest meat processors, declined to comment. A call to Cargill Meat Solutions wasn't immediately returned.

    Rossman said the support is likely to be there. She said the industry has already spent millions of dollars on technologies to fight E. coli in packing houses, and is anxious for strategies that work before slaughter. Her group helped fund research at West Texas A&M University that led the USDA to grant the conditional license. Similar work was also done at Kansas State University.

    Guy Loneragan, who led the research at West Texas A&M, said he did his study at a commercial feedlot to see how the vaccine worked in "real world" conditions. Among the cattle that got it, he said, there was an 85 percent reduction in animals shedding O157. Among those that still did, there were 98 percent fewer cells of the bacteris in their feces. He said that logically should mean fewer E. coli illnesses in people.

    The conditional license allows Epitopix to market the vaccine immediately, but the company must continue conducting potency and efficacy studies to get full licensure.

    Another E. coli vaccine for cattle, developed by Bioniche Life Sciences Inc. of Canada, received full approval there last October and Bioniche is seeking USDA approval to sell it in the U.S. Haq declined to say how soon that might be, but Rick Culbert, president of Bioniche's food safety division, said the main thing left is lining up manufacturing facilities in the U.S., as the USDA requires. A Colorado company, GeneThera Inc., is also working on a vaccine, but it's further away from approval.

    24 mars

    Ways Big Pharma Hides Negative Test Results

    Here's the playbook!
     
     

    Friday, March 20 2009

    Seroquel Lessons: Raised Eyebrows and Furrowed Brows 

    By Cole Werble

    There are several ways to bury adverse research results. One way is not to report the trial; that is getting a lot of media attention. Another is to report competing trials to overwhelm the results from an unfavorable trial. This second technique may present a hurdle to comparative effectiveness research in the future.

     

    A very interesting Washington Post front-page story on March 4 about an unfavorable study on Seroquel that may have been “buried” during clinical development ends with a comment from the principal investigator of the large NIH comparative trial of antipsychotics, the CATIE trial.

    Post writer Shankar Vedantam says “Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, ‘it would raise your eyebrows.’"

    That’s an intriguing observation, especially since Lieberman was not only the lead investigator for the NIH study but also for a smaller comparative study commissioned by Seroquel manufacturer AstraZeneca, which was conducted during the course of the large NIH comparative project.

    As we wrote at the time of the first CATIE results in 2005, AstraZeneca was one of the most aggressive participants in the atypical antipsychotic field in its preparations for the release of comparative information from CATIE.

    During 2003, while CATIE was already underway, AstraZeneca commissioned a 52-week comparative trial of Seroquel, Zyprexa and Risperdal in first-episode psychosis, a trial that closely paralleled CATIE.

    Called CAFÉ (Comparison of Atypicals in First Episode Psychosis), AstraZeneca’s trial even echoed CATIE’s name. Lieberman was the lead investigator on CAFÉ as well as CATIE. The two studies shared about 14 of the sites included in CATIE.

    Lieberman told us at the time of the overlapping studies that the AstraZeneca comparison (against two other atypicals, Lilly’s Zyprexa and Johnson & Johnson’s Risperdal) was designed to compare response from first episode patients, a category that was excluded from the CATIE study.

    That study may have added information about another group of patients but it also improved the results for Seroquel noticeably and gave AstraZeneca something positive to say when the CATIE results were released.

    The recent Post story raises issues about studies that might not have been reported to keep unfavorable information from the light of day.

    The real world is even more complicated. As the CATIE/CAFÉ situation reminds, studies can be designed and run by similar teams that make it difficult to parse a useful meaning from the research.

    During a period while the policy and budget communities in Washington are rallying around comparative effectiveness as a way to align health care spending with the most sensible and cost effective treatments, the CATIE experience is a useful warning of a tough road ahead for that effort.

    Previous experience presages a particularly difficult path ahead for the advocates of comparative research as an educational tool – what could be called the Baucus school of comparative effectiveness.

    The way comparative trials have been run to this point suggests there will be plenty of furrowed, confused brows in the future as well as raised eyebrows.

    21 mars

    Rubella Vaccine Injures 27, Kills One

    300 kids got the shot. 27 of them ended up in the hospital. One of them died. Do you like those odds? Neither do I. I'd rather my kid catch rubella and have spotty skin for a week.
     
     
    COLOMBO, March 20 (Xinhua) -- A 12-year-old female student of a leading school in the Southern Province of Sri Lanka died on Friday morning after some 27 students were hospitalized following vaccination against Rubella on Thursday.

    Students of St. Thomas' Girls School in Matara, about 160 km south of the capital Colombo were admitted immediately after they were given Rubella vaccine.

    H. B. Wanninayake, a Health Ministry official in Colombo said one of the girls died Friday morning.

    Health officials in Matara had given vaccine to about 300 students after which some students had fallen ill and were admitted to the hospital.

    The hospitalized students were given artificial respiration while their blood samples were taken to Medical Research Institute for tests.

    Palitha Maheepala of the Health Ministry said further investigations would be conducted by the Health officials about the incident following a directive by Health Minister Nimal Siripala de Silva. 

    19 mars

    Yet Another Mandatory Vaccine Looms for Pregnant Women

    Of course Reuters (whose CEO is on the Board of Directors at Merck) downplays the side effects, and no one seems to care what happens to those people who get infected with CMV *from* the vaccine...
     
     
    New vaccine may reduce infection in unborn babies
     
    Wed Mar 18, 5:29 pm ET
     

    NEW YORK (Reuters Health) – An important cause of neurological impairment in infants -- infection with cytomegalovirus while they are in the womb -- may be curbed with the use of a new vaccine.

    Most adults have been infected with cytomegalovirus or CMV, usually with negligible consequences. However, when women become infected with CMV for the first time while they are pregnant, there is a danger that their baby will also be infected. In some cases, this "congenital" CMV infection can lead to permanent defects such as hearing loss, vision loss, mental disability, lack of coordination, or seizures.

    Now, a study in this week's New England Journal of Medicine reports that a newly developed CMV vaccine reduces cases of CMV infection in women and has the potential to decrease congenital CMV infection.

    "The development of a vaccine for the prevention of congenital CMV infection was listed as a top priority for the US by a committee of the Institute of Medicine in 2001," Dr. Robert F. Pass, from the University of Alabama, Birmingham, and colleagues point out in the report.

    Finding an effective CMV vaccine, however, has been a challenge. The first trials of a CMV vaccine began over three decades ago. In the present trial, the researchers tested a vaccine containing a protein found on the envelope of cytomegalovirus and an adjuvant to increase the immune response.

    A total of 464 non-pregnant, CMV-negative women, between 14 and 40 years of age, were given three doses of the vaccine or an inactive "placebo" over a six-month period.

    During follow-up, 18 CMV infections were seen in the vaccine group compared with 31 in the placebo group. Further analysis confirmed that women given the vaccine were significantly more likely to remain uninfected over a period of 42 months.

    Ninety-seven women in the vaccine group and 118 in the placebo group became pregnant after vaccination. One congenital CMV infection occurred among 81 live births in the vaccine group, compared with 3 cases among 97 live births in the placebo group.

    Two editorialists comment that although side effects were more common with the active vaccine, they were generally mild in nature, and further studies of the vaccine are therefore acceptable.

    SOURCE: New England Journal of Medicine, March 19, 2009.

    18 mars

    Prostate Screening Exams Worthless

    I knew this, but I figured I'd pass it along.
     
     
    Prostate Cancer Test Found to Save Few Lives
     
    Published: March 18, 2009

    The PSA blood test, used to screen for prostate cancer, saves few lives and leads to risky and unnecessary treatments for large numbers of men, two large studies have found.

    The findings, the first based on rigorous, randomized studies, confirm some longstanding concerns about the wisdom of widespread prostate cancer screening. Although the studies are continuing, results so far are considered significant and the most definitive to date.

    The PSA test, which measures a protein released by prostate cells, does what it is supposed to do — indicates a cancer might be present, leading to biopsies to determine if there is a tumor. But it has been difficult to know whether finding prostate cancer early saves lives. Most of the cancers tend to grow very slowly and are never a threat and, with the faster-growing ones, even early diagnosis might be too late.

    The studies — one in Europe and the other in the United States — are “some of the most important studies in the history of men’s health,” said Dr. Otis Brawley, the chief medical officer of the American Cancer Society.

    In the European study, 48 men were told they had prostate cancer and needlessly treated for it for every man whose death was prevented within a decade after having had a PSA test.

    Dr. Peter B. Bach, a physician and epidemiologist at Memorial Sloan-Kettering Cancer Center, says one way to think of the data is to suppose he has a PSA test today. It leads to a biopsy that reveals he has prostate cancer, and he is treated for it. There is a one in 50 chance that, in 2019 or later, he will be spared death from a cancer that would otherwise have killed him. And there is a 49 in 50 chance that he will have been treated unnecessarily for a cancer that was never a threat to his life.

    Prostate cancer treatment can result in impotence and incontinence when surgery is used to destroy the prostate, and, at times, painful defecation or chronic diarrhea when the treatment is radiation.

    As soon as the PSA test was introduced in 1987, it became a routine part of preventive health care for many men age 40 and older. Experts debated its value, but their views were largely based on less compelling data that often involved statistical modeling and inferences. Now, with the new data, cancer experts said men should carefully consider the possible risks and benefits of treatment before deciding to be screened. Some may decide not to be screened at all.

    For years, the cancer society has urged men to be informed before deciding to have a PSA test. “Now we actually have something to inform them with,” Dr. Brawley said. “We’ve got numbers.”

    The publication of data from the two new studies should change the discussion, said Dr. David F. Ransohoff, an internist and cancer epidemiologist at the University of North Carolina. “This is not relying on modeling anymore,” he said. “This is not some abstract, pointy-headed exercise. This is the real world, and this is real data.”

    Dr. H. Gilbert Welch, a professor of medicine at Dartmouth who studies cancer screening, also welcomed the new data. “We’ve been waiting years for this,” he said. “It’s a shame we didn’t have it 20 years ago.”

    Both reports were published online Wednesday by The New England Journal of Medicine. One involved 182,000 men in seven European countries; the other, by the National Cancer Institute, involved nearly 77,000 men at 10 medical centers in the United States.

    In both, participants were randomly assigned to be screened — or not — with the PSA test, whose initials stand for prostate-specific antigen. In each study, the two groups were followed for more than a decade while researchers counted deaths from prostate cancer, asking whether screening made a difference.

    The European data involved a consortium of studies with different designs. Taken together, the studies found that screening was associated with a 20 percent relative reduction in the prostate cancer death rate. But the number of lives saved was small — seven fewer prostate cancer deaths for every 10,000 men screened and followed for nine years.

    The American study, led by Dr. Gerald L. Andriole of Washington University, had a single design. It found no reduction in deaths from prostate cancer after most of the men had been followed for 10 years. Every man has been followed for at least seven years, said Dr. Barnett Kramer, a study co-author at the National Institutes of Health. By seven years, the death rate was 13 percent lower for the unscreened group.

    The European study saw no benefit of screening in the first seven years of follow-up.

    Screening is not only an issue in prostate cancer. If the European study is correct, mammography has about the same benefit as the PSA test, said Dr. Michael B. Barry, a prostate cancer researcher at Massachusetts General Hospital who wrote an editorial accompanying the papers. But prostate cancers often are less dangerous than breast cancers, so screening and subsequent therapy can result in more harm. With mammography, about 10 women receive a diagnosis and needless treatment for breast cancer to prevent one death. With both cancers, researchers say they badly need a way to distinguish tumors that would be deadly without treatment from those that would not.

    When the American and European studies began, in the early 1990s, PSA testing was well under way in the United States, and many expected that the screening test would make the prostate cancer death rate plummet by 50 percent or more. Dr. Brawley was at the cancer institute then, though not directly involved with its prostate cancer screening study. But he saw the reactions.

    Some urologists said the study was unethical, because some people would not be screened, and demanded it be shut down, he said. One group of black urologists encouraged black men not to participate because blacks have a greater risk of prostate cancer and it seemed obvious they should be screened.

    Some thought that they would see fewer cancer deaths among screened men as quickly as five years. But it became clear that screening would not have a large, immediate effect — if it did, the studies would have been stopped and victory declared. Cancer researchers began turning to less rigorous sources of data, with some arguing that screening was preventing cancer deaths and others arguing it was not.

    In the United States, many men and their doctors have made up their minds — most men over age 50 have already been screened, and each year more than 180,000 receive a diagnosis of prostate cancer. In Europe, said Dr. Fritz H. Schröder of Erasmus University, the lead author of the European study, most men are not screened. “The mentality of Europeans is different,” he said, and screening is not so highly promoted.

    Both studies will continue to follow the men. It remains possible that the United States study will eventually find that screening can reduce the prostate cancer death rate, researchers say, or that both studies will conclude that there is no real reduction.

    “I certainly think there’s information here that’s food for thought,” Dr. Brawley said.

    The benefits of prostate cancer screening, he said, are “modest at best and with a greater downside than any other cancer we screen for.”

    Seasonal Flu Virus "Accidentally" Contaminated with Bird Flu

    The bird flu has turned out not to be a real threat to anyone not living within sh*tting distance from birds and pigs--and the reported case fatality rate is likely highly exaggerated--so of course the only way to scare people into continuing to fund bird flu vaccine reseach is to "accidentally" spread the bird flu via seasonal flu vaccines. Hahahahaha!
     
     

    WHO mulls stricter transport of bio products

    By Andrew Jack

    Published: March 16 2009 22:10 | Last updated: March 16 2009 22:10

    Public health officials are studying the need for tighter controls on the transport of biological products after Baxter, the US pharmaceutical company, inadvertently supplied samples of the H5N1 bird flu virus to a series of European laboratories.

    Specialists from the World Health Organisation and the European Centre for Disease Prevention and Control are monitoring the case at a time of growing concern that existing international rules to minimise the risks of the spread of pathogens are too weak.

    Their scrutiny follows an incident that recently came to light when samples of H5N1 from Baxter’s Austrian labs contaminated batches of the less harmful H3N2 seasonal flu virus that it was supplying under a commercial contract to a customer, Avir Greenhills Biotechnology.

    A combination of H3N2, which is highly transmissable between humans, and H5N1, which has killed hundreds of millions of chickens and other animals in recent years, could potentially lead to a mutated virus that forms the basis of a new human pandemic threatening millions of lives, according to scientists.

    Baxter stressed that the H3N2 strain had been made “replication defective”, and was handled in tightly controlled laboratories purely for experiments, so there was little chance it could have led to an outbreak threatening humans. It also stressed that all staff potentially exposed were tested and given antiviral treatment to prevent any infection.

    Baxter was forced to suspend production last year of Heparin, a blood thinner, after contamination during manufacturing of the primary ingredient in China triggered health alerts in the US, where regulators say it may have contributed to patient deaths. Baxter has refuted the FDA’s claim.

    Baxter said the H5N1 samples were provided for its own research into a pandemic vaccine it is developing, and were from a variant of the virus identified in Vietnam and provided to the company by the US Centers for Disease Control in Atlanta.

    “The material was handled appropriately in all steps of the process in the right conditions,” said Chris Bona, a Baxter spokesman. “The experimental material was produced exclusively for laboratory testing, was not used for product production and was not for use in humans.”

    It somehow mixed with H3N2 before distribution last December to Avir, and the more potent virus was detected by a subcontractor in the Czech republic last month after it rapidly killed ferrets exposed to the viruses. Avir had also sent samples to Slovenia and Germany.

    Mr Bona stressed that Baxter had since taken “corrective preventative actions” and its procedures had been approved by the Austrian authorities.

    The incident comes just after the conclusion of an EU-funded project on biosafety highlighted the need for improvement to national regulatory frameworks for biosafety and laboratory biosecurity.

    17 mars

    Big Chemical Bias at the EPA

    File this one under "shocking."
     
     
    March 15, 2009
    EPA official might have conflict over C8
    The "senior policy counsel" to Environmental Protection Agency Administrator Lisa Jackson has represented 3M Corp., helping the agency deal with EPA efforts to understand - and perhaps regulate - what C8 and similar chemicals are doing to public health and the environment. That link has some critics nervous.
    Staff writer

    CHARLESTON, W.Va. -- When President Obama named Lisa Jackson to be his Environmental Protection Agency administrator, advocates for tougher regulation of the toxic chemical C8 were optimistic.

    Read more in the Sustained Outrage blog.

    As New Jersey's top environmental regulator, Jackson had set the toughest C8 guideline in the country - a drinking water standard of 0.04 parts per billion of C8, also known as PFOA.

    Now those advocates are worried. Last month, Jackson named lawyer Robert M. Sussman to be her "senior policy counsel," to advise her on energy and environmental issues across EPA's broad regulatory authority.

    For several years, Sussman represented 3M Corp., helping the agency deal with EPA efforts to understand - and perhaps regulate - what C8 and similar chemicals are doing to public health and the environment.

    Sussman worked for EPA during the Clinton administration and later became a partner in the Washington office of the Los Angeles law firm, Latham & Watkins.

    After retiring from the law firm, Sussman became a fellow at the Center for American Progress, a liberal think tank run by John Podesta, a former chief of staff for President Bill Clinton.

    Last week, a lawyer for residents of three states where these perfluorinated chemicals, or PFCs, have polluted drinking water wrote to Jackson to urge her to ban Sussman from any involvement in these issues.

    "What is not clear ... is the scope of the policy issues for which USEPA will be looking to Mr. Sussman to provide counsel," wrote Robert A. Bilott, who represents residents in West Virginia, New Jersey and Minnesota whose drinking water is contaminated.

    "The scope of those interactions is of concern to us because of the extent to which Mr. Sussman was directly involved in representing the interests of perfluorochemicals manufacturers in negotiations with USEPA while he was a partner at Latham & Watkins," Bilott wrote.

    "Because current issues will likely require your office to assess what particular policies to pursue with respect to perfluoro-chemical contamination of drinking water supplies, we are concerned by the conflict that could arise if Mr. Sussman were involved in any way with any of those issues while at USEPA," he wrote.

    Bilott asked that EPA "confirm that Mr. Sussman will have no involvement of any kind in any perfluoro-chemical issues while working at USEPA, including any negotiations within the agency or with outside parties, preparation or transmittal of communications within the agency, to or from other agencies at the state or federal level, or to or from the public (including the press and Congressional staffs), or other contacts."

    Also, Bilott asked that EPA "detail the specific procedures that have been put or are being put in place to ensure that Mr. Sussman has no involvement whatsoever with any perfluoro-chemical issues while working for USEPA, and we request that USEPA provide copies of documentation specifying the procedures established to address this situation."

    Sussman did not return a phone message left on his voice mail at EPA headquarters last week.

    On Friday, EPA press secretary Adora Andy said Sussman would be recused from these issues, but declined to provide further details on the scope and mechanics of that recusal.

    With his letter, Bilott sent EPA more than 100 pages of documents that outline some of Sussman's involvement in C8-related issues for St. Paul, Minn.-based 3M.

    For more than 50 years, 3M produced C8 and related chemicals used in popular products such as Scotchgard and Teflon.

    In May 2000, 3M announced it was phasing out production of these chemicals. 3M officials took that step after learning of a DuPont Co. study in which monkeys exposed to C8 had to be killed because they were suffering from such severe health effects, according to government records. 3M also moved to phase out C8 production after being warned the EPA was considering more strictly regulating such chemicals.

    3M is still facing a lawsuit from Minnesota residents who say their drinking water has been contaminated with PFCs from the company's operations. And 3M was very involved in a now-abandoned EPA "enforceable consent agreement," or ECA, process, meant to lead to tougher regulation of these chemicals.

    Among other things, the documents Bilott sent to EPA show Sussman was involved in justifying private discussions 3M had with EPA during the ECA process, which was supposed to be conducted in public.

    "We understand EPA has some questions about the appropriateness of direct discussions like today's call while the ECA process is still ongoing," Sussman wrote in a May 2004 e-mail message. "We've thought about this issue and don't see such discussions as a 'process foul.'

    "We see great value in senior managers from industry periodically touching base with their counterparts at EPA," Sussman wrote. "This enables us - as we're doing today - to provide candid feedback on the successes and frustrations of the ECA process and how we can make it more productive."

    Reach Ken Ward Jr. at kw...@wvgazette.com

    or 304-348-1702.

    13 mars

    Windex Loaded with Phthalates, Sunoco Takes a Stand on BPA, Plastics Fill Ocean

    Three pieces of news on plastics and plasticizers, and one and a half of them are good:
    (1) Plastics bags represent 12 percent of beach trash--but you knew that, if you've been reading about the giant plastic islands floating in our oceans.
    (2) Windex and other popular cleaning products are loaded with toxic phthalates, but SC Johnson is planning to phase them out. Whatever, guys. I use a 50/50 solution of vinegar and water instead of Windex. It cleans just as well, and it's super-cheap.
    (3) Sunoco won't sell you BPA if you're planning to put it in a children's product. Now *that* is courage. BPA is a known carcinogen (see www.ewg.org for more info), and at least one Big Oil company won't be part of the poisoning anymore. Dow, Bayer, and Hexion, on the other hand, are ready and willing to continue to hawk their toxins to the highest bidder. Thanks, man.
     
     

    Study ranks plastics' share of marine debris problem

    By Mike Verespej | PLASTICS NEWS STAFF
    Posted March 12, 2009
    WASHINGTON (March 12, 4:20 p.m. ET) -- Plastics bags and food wrappers/containers are the second- and third-most common items in marine debris globally, according to a report released Feb. 25 by the non-profit organization, the Ocean Conservancy, based in Washington.

    What’s more, of the 43 items tracked, six of the top eight were plastic or categories that are heavily plastic. Cigarettes were the top item found and paper bags the fifth-most common item. The calculations were made based on a global marine collection day in September that was conducted at 6,485 sites in 104 countries, 42 U.S. states and the District of Columbia.

    In all, 6.8 million pounds of trash were collected or 400 pounds of debris for every mile of beach.

    Plastic bags represented 12 percent, or almost 1.38 million, of 11.4 million items collected, food wrappers and containers 8 percent, caps 8 percent, plastic beverage bottles 6 percent, straws and stirrers 4 percent and cups, plates, knives, forks and spoons another 4 percent.

    The top eight items accounted for 75 percent of the litter, with cigarettes and cigarette filters accounting for 28 percent of the items found, paper bags 5 percent and glass bottles and beverage cans, four percent apiece.

    “Sadly, people keep dropping trash everywhere where it can reach the ocean,” said the report. “All readily fall from human hands and can be easily contained if disposed of properly. Humans have created the marine debris problem and humans must take responsibility for it.”

    The report said 443 animals were founded entangled or trapped in marine debris, with fishing-related items accounting for 69 percent of the cases where animals were trapped. The report said 268 of the animals were found alive and released.

    Included among the group’s six recommendations was that people reduce, reuse and recycle.

    “Much of what winds up in the ocean wasn’t truly necessary in the first place,” said the report. “We can produce less packaging up front and cut back on debris through recycling and the routine use of cloth grocery bags.

    “The marine debris problem is solvable, and often through relatively simple measures,” said the report. “Elected officials can make informed policy decisions, community leaders can tailor and expand recycling and other trash-reduction programs, corporate decision-makers can improve technology and reduce packaging, and individuals can recycle, reuse or properly dispose of trash.”

    In addition to litter, the report said that items such as syringes, disposable diapers and female sanitary products enter waterways through sewer systems.

    * * *

    http://www.usatoday.com/news/health/2009-03-12-scjohnson_N.htm

    Maker of cleaners to scrub some chemicals from products

    By Liz Szabo, USA TODAY
    S.C. Johnson announced Thursday that it's removing controversial chemicals called phthalates from Windex, Shout, Pledge and its other popular cleaning products, and will begin disclosing all ingredients on its labels.

    The company plans to phase out phthalates, chemicals that interfere with the hormone system and have been linked to genital abnormalities in newborn boys, within two years, the company said in a statement.

    The company believes that phthalates are safe, says chairman and chief executive officer Fisk Johnson. But the company is removing the chemicals because of consumer concerns, he said in a statement.

    "Listening and responding to consumers is S.C. Johnson's top priority," Johnson said in the statement. "Making information about the ingredients in our products readily accessible and easy to understand helps our consumers know they can continue to trust our products."

    Environmentalists and consumer health groups have strongly criticized the makers of household cleaners for refusing to include a complete list of ingredients on its labels, including dyes, preservatives and fragrances. Only a handful of household cleaning brands, such as Seventh Generation, list every ingredient.

    By January 2012, S.C. Johnson will list its ingredients not only on labels, but also on a company website, whatsinsidescjohnson.com, and through a toll-free number, 1-800-558-5252.

    Health and environmental advocates welcomed the change. Many health advocates say the changes are especially significant given that S.C. Johnson products are used in 99 million American homes.

    Listing ingredients is especially important for people with allergies, lung disease or families with small children, "whose growing lungs need special protection," says Charles Connor, president and chief executive officer of the American Lung Association.

    The Natural Resources Defense Council says it hopes others in the industry will follow S.C. Johnson's example.

    "A trip to the drugstore or supermarket shouldn't turn into a guessing game," said Frances Beinecke, president of the Natural Resources Defense Council, in her blog today. "Their customers will now be able to make informed choices."

    In her blog, Beinecke noted that the defense council last year had to take air fresheners to a lab for expensive tests to find out their ingredients. The council found that many air fresheners have high levels of phthalates.

    Beinecke notes that household cleaners may still contain harmful ingredients. But listing ingredients and phasing out phthalates is "a critical first step."

    Environmentalists have won a number of key victories in the past year in their fight to stop the use of controversial chemicals in consumer products.

    Congress virtually banned lead and six phthalates in children's products in a law that took effect in February.

    The country's leading baby bottle manufacturers last week announced that they will stop using an estrogen-like chemical called bisphenol A, or BPA, in their plastic bottles. A large study in The Journal of the American Medical Association in October linked BPA to heart disease and diabetes, and animal studies have linked it to other health problems.

    Beinecke and others say these changes show that the marketplace is listening to customers.

    "People who buy S.C, Johnson products let the company know they were concerned about ingredients," Beinecke says. "The company's response is a testament to the power of consumers to make a difference."

    * * *

    http://www.google.com/hostednews/ap/article/ALeqM5gOPl1ZUc7b5Zxrt5oXVoyFC24GTQD96SMQH80

    Sunoco restricts sales of chemical used in bottles

    By MATTHEW PERRONE – 1 day ago

    WASHINGTON (AP) — Sunoco has begun restricting sales of a controversial chemical used in baby bottles and food containers that some researchers believe can harm infants.

    The move by the gas and chemical giant makes Sunoco the first manufacturer to acknowledge safety concerns about bisphenol-A, or BPA, which recently led retailers like Wal-Mart to pull thousands of baby and water bottles off store shelves.

    Environmental groups want to ban BPA in products for infants because of concerns that it can interfere with biological functions needed for growth. But government scientists have issued conflicting opinions about the chemical's risks.

    In light of that uncertainty, Sunoco said in a letter Thursday it has begun requiring customers to guarantee that its BPA will not be used in food and water containers for children under 3.

    "We will no longer sell BPA to customers who cannot make this promise," Thomas Golembeski, head of public relations, wrote in a letter to two investors.

    The company's policy, which took effect last November, was prompted by concerns from local investors, including an order of Franciscan nuns.

    "We thought this was a really bold step, especially for a company that's a member of the American Chemistry Council," said Tom McCaney, associate director for corporate responsibility at the Sisters of St. Francis of Philadelphia, a group of about 600 nuns.

    The American Chemistry Council, an industry trade group, has reiterated that BPA is among the most-tested chemicals ever produced and is safe for adults and infants.

    Philadelphia-based Sunoco is a relatively small player in the market for BPA, which is used to make everything from CDs to pipes to glasses frames. Larger producers include the Dow Chemical Co., Bayer and Hexion Specialty Chemicals.

    Those companies did not immediately respond to requests for comment.

    Last year U.S. production of BPA reached an estimated 950,000 metric tons, according to the Chemical Marketers Associates. That number was down 5 percent from the prior year, as chemical makers were hammered by soaring energy prices and lower consumer spending.

    Last week six of the nation's baby bottle makers, including Gerber and Playtex Products, said they will stop using BPA, at the request of attorneys generals in several states.

    Major U.S. retailers, including Toys 'R' Us Inc. and Wal-Mart, have removed products containing the chemical from their stores. And last fall Canada banned BPA from all baby bottles.

    About 90 percent of Americans have traces of bisphenol in their urine. Among hundreds of other applications, the plastic-hardening chemical is used to seal cans and often leaches into canned food.

    But while the kidneys of older children and adults quickly eliminate the chemical from their bodies, newborns and infants may retain it for much longer.

    Consumer advocates want restrictions on BPA because it mimics the effects of the hormone estrogen, potentially interfering with young, growing bodies.

    They point to dozens of studies in animals showing low doses of the chemical led to increases in breast, prostate and uterine tumors. However, most of those studies relied on a small number of animals, and the results have not been confirmed in humans.

    The FDA concluded last year that there is no harm from the low doses of BPA that babies, children and most adults get by eating foods from containers made with BPA.

    But the agency's own outside advisers faulted that report for relying on a small number of industry-sponsored studies and creating "a false sense of security." The advisers said more studies of the chemical are needed, though it will likely take years to gather more conclusive evidence.

    AP Business Writer Ernest Scheyder contributed to this story from New York

     

    12 mars

    Two Good Things Obama Is Doing

    I didn't vote for the guy, but I didn't like GWB, either. Here are two good things Obama is doing to bring transparency to the toxic world in which we live.

    http://www.google.com/hostednews/ap/article/ALeqM5iQcNx7B2Lu7Lu_gzk1yEmxsKoXtQD96S20SO0

    Spending bill removes Bush limits on toxic reports

    By DINA CAPPIELLO – 1 day ago

    WASHINGTON (AP) — The $410 billion spending bill that President Barack Obama signed Wednesday will reinstate detailed toxic chemical reporting at more than 3,500 facilities nationwide.

    The Bush administration in 2006 reduced the amount of information that facilities storing and releasing smaller amounts of toxic chemicals had to submit to the federal government. Companies using less than 5,000 pounds of toxic chemicals, or releasing less than 2,000 pounds, could use shorter, less detailed forms. Congressional auditors said the change would have cut by a quarter the number of emissions reports the government receives each year.

    A provision in the spending bill eliminates the Bush change, which was pushed by the White House to reduce the regulatory burden on industry. Democratic lawmakers have criticized the regulation, and a dozen states have sued the Environmental Protection Agency arguing it reduces the information available to the public about chemical hazards in their communities.

    Sen. Frank Lautenberg, D-N.J., who authored the portion of the 1986 law requiring toxics reporting, sponsored the measure. He said it restored the public's right to know about chemicals in their air and water.

    It is unclear whether the EPA will be able to restore full reporting by July 2009, when the latest emissions reports are due. Also unresolved is the effect of the provision on the lawsuit.

    The toxics rule is just one of several leftover Bush administration environmental policies targeted by the bill. It also clears the way for the Obama administration to reverse a rule that says greenhouse gases may not be restricted to protect polar bears from global warming. Another Bush rule that reduced the input of federal scientists in endangered species decisions can also now be quickly overturned.

    (This version CORRECTS year in 5th graf, to 2009 sted 2008.)

    * * *

    http://michiganmessenger.com/14472/epa-to-expedite-report-on-dioxin-danger


    EPA to ‘expedite’ report on dioxin danger

    Cleanup of toxin has been hampered by lack of clear information on health risks


    By Eartha Jane Melzer 3/11/09 8:35 AM

    Environmental Protection Agency said this week that it will try to speed the release of its reassessment of dioxin, a chemical that has contaminated Michigan’s largest watershed.

    Dioxin, a by-product of the chemical manufacturing process, has long been known as a carcinogen and is regulated by state and federal agencies. EPA studies of the chemical since 1991 have indicated that the substance is far more toxic that previously thought (pdf) — capable of damaging the endocrine and immune systems and changing fetal development at common background levels — but political pressures have delayed the official release of these findings.

    “The new administration is familiar with the history of this issue and will be focusing on expediting the study,” EPA spokeswoman Suzanne Ackerman said this week.

    “We’re pleased to hear EPA plans to expedite the study,” said Mike Schade of the Virginia-based Center for Health, Environment and Justice, which together with 100 other groups sent a letter to the Obama administration in late January asking that the dioxin reassessment be released.

    “As a first step, EPA should cancel the unnecessary [Science Advisory Board] review and release the Dioxin Reassessment so that the EPA and others can move forward in developing protective dioxin policies and standards.”

    Schade said that a further review of the report, which has existed in draft form since the early ’90s, would delay the release of the report for years.

    “While panels are convened,” he said, “people in communities across the country are continued to be exposed to this highly toxic chemical.”

    Last year the Government Accountability Office recommended that the EPA adopt a streamlined process for completing the dioxin study but noted that the Bush administration EPA chose not to adopt its proposal.

    In a January report to Congress the Government Accountability Office said that EPA’s delays in releasing the dioxin reassessment pose a high risk for public health. The agency wrote:

    Although dioxin is a known cancer-causing chemical to which humans are regularly exposed by eating such dietary staples as meats, fish, and dairy products, actions to protect the public will likely be delayed until the assessment is complete. Since EPA estimates that the assessment process for complex chemicals such as dioxin could take 6 to 8 years to complete, the public in the meantime will likely remain at risk.

    In Michigan, operations at Dow Chemical’s Midland plant have contaminated 50 miles of the Saginaw Bay watershed with dioxin.

    Last week EPA announced a freeze on cleanup negotiations with Dow that were begun in the final days of the Bush administration and which were criticized for lack of transparency. Also last week, Dow announced that it would remove dioxin contamination at Saginaw Township’s West Michigan Park.

    Dow also appeared in the State Supreme Court, which is expected to rule on whether an environmental class action suit against the company can proceed.

    Yale Shills for Merck

    Here's another one for the "Merck's check cleared" file...

    Yale Alumni Magazine reports on the work of epidemiologist Alison Galvani, who does her work at the Yale School of Public Health but has been on Merck's payroll since 2003, according to her CV. Galvani did a marketing study for Merck on Gardasil that she somehow passed off as research; her study asked parents whether they thought their daughters would become more promiscuous if they were given Gardasil. Yale Alumni Magazine's writer (Jenny Blair, who is a Yale-educated MD) apparently didn't read the published results from the *Proceedings of the National Academy of Sciences* because she says "Side effects were a minor concern" for parents in deciding whether to give their daughters Gardasil--I read the published results, and nowhere in the paper does Galvani mention asking survey participants about side effects... although she does fleetingly note that parents have concerns in her introduction to the paper.
    Dr. Blair's pro-pharma writeup of the research also calls Gardasil "a safe and effective vaccine against HPV"--I wonder who told her that? Merck, or their paid-off researcher Galvani?

    The icing on the cake is that Galvani asserts in her paper that "There is no evidence that perceptions of increased adolescent sexual promiscuity are based on reality." No evidence is given for this statement; it is just pronounced, as if thinking makes it so. I am unaware of *any* data on the promiscuity effects of STD vaccines given to preteens and teens--maybe because Gardasil is the first STD vaccine given to a sexually active (or soon-to-be sexually active) group!
    Beyond the fact that no one has ever evaluated the promiscuity consequences of STD vaccination of teens, Galvani didn't ask her survey participants a more important question: whether they believe HPV vaccination will make their daughters less likely to use protection such as condoms when engaging in sexual activity. Even if you think your daughter is just as likely to be promiscuous whether or not she receives Gardasil, you might believe (and you might be right) that she will be more careless about protecting herself from pregnancy, AIDS, etc., when she does have sex.

    The alumni magazine's Dr. Blair concludes (parroting from Galvani's market research for Merck), "a targeted public health education campaign would likely counter fears of increased promiscuity. And a little financial aid wouldn't hurt." Given that both insurance premiums and the federal government's Vaccines for Children Program currently subsidizes Gardasil's production and administration, I guess Galvani and Merck are really asking for a little *more* financial aid... and maybe the reason Merck (and the government) haven't been running ads to the effect of "your daughter won't be any more promiscuous if you give her Gardasil" is that there is no data to back up that assertion, however much Galvani and Merck want it to be true.

    (Links here:
    http://www.yalealumnimagazine.com/issues/2009_03/findings_hpv.html
    http://www.ncbi.nlm.nih.gov/pubmed/19015536?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
    I paid $10 for access to the article to make sure nothing about side effects was left out of the abstract... No surprises there.)
    11 mars

    More Makeup to Avoid

    The US hasn't seen fit to ban these chemicals, but Canada has. You can read the labels on the crappy products still on American store shelves (or you can just buy Nvey Eco and Suki here).

    http://pubs.acs.org/cen/news/87/i11/8711news4.html

    March 10, 2009

    Regulation

    Canada Targets Cosmetic Chemicals

    Government to ban four chemicals used in cosmetics because of health hazards concerns

    Cheryl Hogue

    As part of its ongoing assessment of commercial chemicals, the Canadian government on March 7 announced it would ban the use of four substances in cosmetics.

    The government says the compounds could pose a hazard to human health, although the public's exposure to the chemicals in Canada is low.

    One of the substances is 2-methoxyethanol acetate, an industrial solvent found in some nail polishes and glues. According to the governmental agencies Health Canada and Environment Canada, exposure to the chemical may interfere with fertility and harm the developing fetus.

    Another of the compounds slated for regulation is 2-methy-1-propanol, which is used to make propylene glycol monomethyl ether (PGME). Consumer products made with PGME, such as nail polish, nail polish remover, hair spray, hair dye, and false eyelash adhesive and remover, may have small amounts of 2-methy-1-propanol, say Health Canada and Environment Canada. According to the agencies, 2-methy-1-propanol may adversely affect fetal development.

    The Canadian government plans to prohibit use of PGME in cosmetics if it contains concentrations of 2-methy-1-propanol more than 0.5%.

    In addition, the government is seeking data on levels of 2-methy-1-propanol in food packaging. The chemical may be an impurity in solvents used to manufacture paperboard and plastic food packaging, the agencies say. The solvents, however, aren't expected to be in the finished packaging.

    A third chemical affected by the Canadian action is 2-(2-methoxyethoxy) ethanol, listed on cosmetic labels as methoxydiglycol and also known as DEGME. This substance may impair fertility and harm developing fetuses, the agencies say. A small number of cosmetics sold in Canada contain this compound, they add.

    Methoxydiglycol is also in some latex paints, paint removers, sealants, floor polish, and floor cleaner, according to the agencies. The government will continue to study the chemical to determine whether further regulatory action is needed to protect the public.

    The final substance affected by the action is Pigment Red 3, used mainly in paints but found in a few cosmetics. The compound caused cancer in some experiments with laboratory animals. The agencies will investigate whether the government needs to take further action on Pigment Red 3 to protect health.

    More information is available at chemicalsubstanceschimiques.gc.ca/en/index.html.

    Obama Decides Big Pharma Is A-OK

    Maybe it was the PAC contributions. Whatever the case, it's a little disheartening to see that Obama is focusing his attention on Big Tobacco rather than Big Pharma...

    http://therpmreport.com/Free/f091b7e4-0866-47bc-8ff3-5e2837580fd5.aspx?utm_source=RPMel

    Monday, March 09 2009

    Smoke Signals Look Good for Pharma 

    By Cole Werble

    The smokeless backrooms of politics in Washington 2009 are looking like a good environment for the biopharma industry -- better even than the deals that emerged from the smoke-filled rooms of lore.

     

    This could very easily have been a year of multiple political threats to the industry with the drug business portrayed as a scapegoat for out-of-control health costs, but it is emerging instead as a year offering reasonable compromises and proposals to protect pharma pricing and give the industry access to significant new markets.

    The first signs that the biopharma sector may have crawled out of the bulls-eye as a target for health reform are (1) the Obama Administration's decision to turn back to the tobacco industry as the number one health villain and (2) relatively small financial contributions expected from the biopharma sector to pay for health care reform.

    As we have written recently, tobacco regulation is next on Capitol Hill agenda for the Democrats. Getting rid of cigarette smoke has become a core issue for the new administration despite the fires incinerating the other parts of the economy. The campaign against smoking is more accurately a "Corr" issue for the administration, supported by the HHS Deputy Secretary-designate, William Corr, a long-time ally of House Energy & Commerce Chairman Henry Waxman (D-CA) and long-time critic of the tobacco industry.

    No matter how the anti-smoking campaign found its way into the packed Obama agenda, the fact that it is there means that pharma immediately becomes a lesser evil on the list of industries affecting US health care.

    Pharma is well aware of the smoke-screen and regulatory/political cover that the tobacco industry presents. Even before the 2009 legislative season was underway, Pharmaceutical Research & Manufacturers of America President Billy Tauzin was expressing full support for the government to go aggressively after tobacco regulation.

    "Any work" the government could do "to prevent people from smoking is good work," Tauzin declared, saying "tobacco is not our friend." It is a point not lost on a political pro like former House Energy & Commerce Chairman Tauzin that pharma experienced its best years of growth and new product introductions while the Food & Drug Administration was absorbed in its fight against the tobacco companies in the late 1990's.

    The anti-smoking position allows Tauzin to talk positively about health reform. He took his prevention rhetoric to the White House Summit where he talked about the importance of healthier lifestyles. He claimed that 67 percent of cancers could be avoided if people did not smoke, ate properly and exercised.

    Tobacco regulation can be a distraction for FDA's senior management and take up a lot of the agency's resources, but it creates a less pressured atmosphere for drug regulation.

    Health Reform Hurts But Pharma Is Not Getting the Worst of It

    The second sign of a developing positive atmosphere for biopharma is the relatively small $29 billion that the industry will be expected to contribute to the $634 billion down payment fund for Obama's health care reform initiative. That is the amount the federal government will collect from increased Medicaid rebates. Pharma will actually face additional payments to the states of about $12 billion more (for a total of $41 billion). The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years.

    That sounds like a lot but compare that number to $117 billion that the health insurers are being asked to give up to the federal government from reductions to Medicare Advantage payment rates.

    From that perspective, you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them. It also becomes clearer why biopharma leaders are accepting the proposed payments more stoically: they are being asked for less and have a lot to gain if insurance coverage can be more widely extended to the currently uninsured and under-insured -- a potentially large new market for pharmaceuticals.

    The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a gopod climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics.

    By supporting Corr's anti-smoking effort, pharma improves it relationship with a key figure for the FOBs bill. Corr was the staff architect for Waxman behind the original Waxman-Hatch generics bill 25 years ago. He is likely to be the driving force behind getting a follow-on deal done this year. He is no friend of pharma; but having the smoking issue as background is very convenient for biopharma.

    Legislative control over co-pays is getting less public attention but could be the big money issue for pharma in the current legislative season -- especially as specialty drugs and biologics become more important to the industry.

    Both BIO and PhRMA have identified efforts to restrict the amount of out-of-pocket expenditures that patients will have to make for drugs as important to their policy agendas. This is an access issue for patients that offers an indirect price protection to the industry. If pharma can avoid high co-pays, that will permit them more flexibility for high prices.

    The objective is to make sure that health insurers and Part D Medicare plans cannot set co-pay levels so high as to act as a de facto barrier against patient use of the products. The drug industry senses that controls on co-pays are politically viable in a Democratically-controlled Washington because they can be presented as a patient/beneficiary access issue.

    The Democratic election did not seem like good news for pharma in November and it still could turn out badly, but things have started out pretty well.

    FDA Cites Genzyme, But Aims to Speed up Nanotech

    ...because in the world of a woefully understaffed (and financially conflicted) FDA, I totally trust the government to patrol new nanotechnology products adequately! Not.

    http://online.wsj.com/article/SB123669797974884201.html?mod=dist_smartbrief

    • MARCH 11, 2009

    FDA Warns Genzyme on Plant Conditions

    Agency's Critique of Production Could Further Delay Biotech Company's Pompe Drug


    U.S. Food and Drug Administration investigators found "significant objectionable conditions" during an inspection of a Genzyme Corp. plant that makes expensive biotechnology drugs, according to a copy of an agency warning letter.

    The Feb. 27 letter outlines a number of deficiencies in the manufacturing process at the Boston plant, which produces some of the company's best-selling products, including drugs such as Myozyme, Cerezyme and Fabrazyme.

    Genzyme last week disclosed the existence of a warning letter from the FDA but didn't release the details of the communication. The FDA released a redacted copy of the letter after a request by The ...



    * * *
    http://www.upi.com/Science_News/2009/03/10/FDA_to_speed_nanomedical_product_creation/UPI-97701236710622/

    FDA to speed nanomedical product creation



    WASHINGTON, March 10 (UPI) -- The U.S. Food and Drug Administration says it will collaborate with the Alliance for NanoHealth to speed creation of safe nanotechnology medical products.

    The FDA said it and the alliance's member institutions will cooperate in a nanotechnology initiative to "expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products."

    "FDA's nanotechnology initiative with the Alliance for NanoHealth is an effort to engage resources and technical expertise in this rapidly advancing field and is a clear example of leveraging science and scientists to advance the public good," said the FDA's Acting Commissioner, Dr. Frank Torti. "Nanotechnology holds great promise for the advancement of novel medical products."

    The alliance's eight academic institutions are the Baylor College of Medicine, the University of Texas' M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston and the Methodist Hospital Research Institute in Houston.

    9 mars

    Home of Corn to be Contaminated with GMOs

    This is the beginning of the end for the beautiful and diverse corn of Mexico. I wonder how much money Monsanto has spent on making this happen.

    http://www.google.com/hostednews/ap/article/ALeqM5jCOPBLPFuOHGwavWRajJoLv4I1QAD96OPAE83

    Mexico allows GM corn for experiments

    2 days ago

    MEXICO CITY (AP) — Mexico is changing its laws to allow the planting of genetically modified corn for experimental reasons.

    Growers will now be able to apply for government permission for experimental plots. The law published Friday in the official registry does not specify limits on how much GM corn can be planted or where.

    Mexico is the birthplace of corn and had banned GM varieties completely until now.

    Environmental groups oppose the measure, calling it the first step toward widespread cultivation of GM corn.

    Opponents warn that modified corn could contaminate fields and threaten the crop's genetic diversity. Mexico has more than 200 varieties of corn.

    The government has not said whether it plans a general legalization of GM corn.